# K080639: Symphony Glucose Management System

- Pathway: 510(k) (Traditional)
- Applicant: Animas Corp.
- Decided: Jun 24, 2008 after 110 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950727 (1995). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042873: Animas Model IR1250 Insulin Infusion Pump, Animas Corp. (2004) Summary page 1.
- K021819: One Touch Ultrasmart Blood Glucose Monitoring System, Lifescan, Inc. (2002) Summary page 1.
- K043197: Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring System, Lifescan, Inc. (2005) Summary page 1.
- K053529: Onetouch Ultra 2 Blood Glucose Monitoring System, Lifescan, Inc. (2006) Summary page 1.
- K030531: Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter, Minimed, Inc. (2003) Summary page 1.
- K040603: Paradigm Link Blood Glucose Meter, Becton, Dickinson & CO (2004) Summary page 1.
- K042792: Ixl-II Diabetes Management System, Insulet Corporation (2005) Summary page 1.

## Most influential descendants
- K083225: Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System (2009), 0 descendants of its own
- K082590: Symphony Meter Remote (2008), 0 descendants of its own

## Recalls of this device
- Mar 1, 2012 · Not classified · Z-1376-2012: There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 201
- Mar 18, 2010 · Not classified · Z-2394-2010: sensor could be damaged
- Dec 18, 2009 · Not classified · Z-1560-2010: Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are un
- Oct 27, 2008 · Not classified · Z-0955-2009: incorrect dosing recommendation
- Aug 4, 2008 · Not classified · Z-0290-2009: Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of
- Aug 4, 2008 · Not classified · Z-0291-2009: Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of
- Aug 4, 2008 · Not classified · Z-0283-2009: display old, inaccurate values for bolus amount delivered and amount of planned bolus totals

## Indications for use
The Symphony System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood. The Symphony Pump is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.

Source page: https://510kreport.com/device/K080639
Methodology: https://510kreport.com/methodology